Action Observation Therapy in Children With Spastic Diplegia (AOT/CP)
11 de junio de 2026 actualizado por: Esraa Elsayed Ali Hassan Elkiky, Cairo University
Effect of Live Versus Video Action Observation Training on Balance and Gait in Children With Spastic Diplegia
The aim of this study is to compare the effect of live versus video action observation training (AOT) on balance and gait in children with spastic diplegia.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Descripción detallada
Children with spastic diplegic often face difficulties with balance and walking, affecting their independence and quality of life. Because of the impact of reduced gait speed and other gait abnormalities on their participation and quality of life, the main focus of physical therapy interventions is to improve balance and gait of children with cerebral palsy (CP).
Action observation training is a developing rehabilitation based on mirror neurons that activate when one performs movements or observes the movements of others. It is applied to improve motor skills and learning in athletes, healthy people, and patients with motor disorders.
Although many studies have focused on the application of action observation training (AOT), especially in improving upper limb function in individuals with stroke or children with CP, there is still a lack of sufficient research examining its effects on spasticity, gross motor abilities, balance, and gait in children with CP.
There is one study comparing the effects of live and video forms of AOT on upper limb function in children with hemiparetic CP. The researchers found that live AOT was more effective than video AOT in improving upper limb performance.
To our knowledge, there are no previous studies that compare the effect of live and video forms of AOT on balance and gait in children with spastic diplegia. Addressing this gap may provide valuable insights into the optimal mode of AOT delivery for enhancing balance and gait.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
45
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Esraa Elsayed Ali Elkiky, M.Sc
- Número de teléfono: +20 10 92002696
- Correo electrónico: esraa.elkiky@gmail.com
Copia de seguridad de contactos de estudio
- Nombre: Mai Elsayed Abbass, PhD
Ubicaciones de estudio
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Giza, Egipto, 12511
- Outpatient clinic of the Faculty of physical therapy, Cairo University
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Contacto:
- Esraa Elsayed Ali Elkiky, M.Sc
- Número de teléfono: +20 10 92002696
- Correo electrónico: esraa.elkiky@gmail.com
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- Children of diplegia who walk by a crouch gait.
- The age of the selected children will range from 4 to 7 years old.
- Degree of spasticity will range from 1 to 1+, according to modified Ashworth scale (MAS).
- They will be selected as Level II according to Gross motor function classification system (GMFCS).
- They will be able to understand the tasks and researchers' instructions.
- Their heights are not less than 1 meter to be able to see the screen of the Biodex balance system.
Exclusion Criteria:
- Visual or auditory impairments.
- Vestibular impairments.
- Fixed deformities of the upper, lower limbs, and the spine.
- Botulinum toxin (Botox) injection for the last six months.
- Orthopedic surgeries in the last six months.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Comparador activo: A selected physical therapy program
Fifteen children will receive one hour of a selected physical therapy program, three times per week for 3 months.
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Participants will receive a conventional physical therapy program, 3 sessions per week for 3 months.
The program will include approximation exercises, balance training, functional activities (sit-to-stand, squatting, stair climbing), gait training with obstacles, walking exercises on different surfaces, and stretching exercises for the upper and lower limbs.
The intervention aims to improve balance, mobility, coordination, and functional performance.
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Experimental: A selected physical therapy program + Live action observation training (AOT)
Fifteen children will receive 30 minutes of the same selected physical therapy program plus 30 minutes of live AOT, three times per week for 3 months.
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Participants will receive a conventional physical therapy program, 3 sessions per week for 3 months.
The program will include approximation exercises, balance training, functional activities (sit-to-stand, squatting, stair climbing), gait training with obstacles, walking exercises on different surfaces, and stretching exercises for the upper and lower limbs.
The intervention aims to improve balance, mobility, coordination, and functional performance.
Participants will receive live AOT for 30 minutes, 3 times per week, for 3 months.
Each task will involve 3 minutes of observing the therapist performing the activity, followed by 3 minutes of verbal guidance and 3 minutes of task execution by the child.
A 1-minute rest period will be provided between tasks.
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Experimental: A selected physical therapy program + Video action observation training (AOT)
Fifteen children will receive 30 minutes of the same selected physical therapy program plus 30 minutes of video AOT, three times per week for 3 months.
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Participants will receive a conventional physical therapy program, 3 sessions per week for 3 months.
The program will include approximation exercises, balance training, functional activities (sit-to-stand, squatting, stair climbing), gait training with obstacles, walking exercises on different surfaces, and stretching exercises for the upper and lower limbs.
The intervention aims to improve balance, mobility, coordination, and functional performance.
Participants will receive video-based AOT for 30 minutes, 3 times per week, for 3 months.
They will observe task demonstrations presented on a computer screen from multiple viewing angles, followed by guided practice and task performance, similar to the live AOT protocol.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Overall Stability Index (OSI)
Periodo de tiempo: 3 months
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It will be assessed using the Biodex Balance System.
Participants will stand on a dynamic platform at stability level 5 for three 30-second trials.
The Overall Stability Index (OSI) will be recorded as a measure of postural stability in all directions.
Lower OSI values indicate better balance control and greater postural stability.
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3 months
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Anteroposterior Stability Index (APSI)
Periodo de tiempo: 3 months
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It will be measured using the Biodex Balance System during dynamic balance testing.
APSI reflects the participant's ability to maintain balance in the forward and backward directions.
Lower APSI scores indicate improved anteroposterior postural control.
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3 months
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Mediolateral Stability Index (MLSI)
Periodo de tiempo: 3 months
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It will be assessed using the Biodex Balance System.
MLSI evaluates the participant's ability to control balance in the side-to-side direction during dynamic standing.
Lower MLSI values indicate better mediolateral stability and balance performance.
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3 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Hip Flexion Angle
Periodo de tiempo: 3 months
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It will be assessed using Kinovea motion analysis software during gait.
Reflective markers will be placed on anatomical landmarks, and participants will walk at a self-selected speed while being recorded with a high-definition camera.
Hip flexion will be measured during the late swing phase, corresponding to peak hip flexion.
Greater hip flexion angles toward normative values will indicate improved gait kinematics.
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3 months
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Knee Flexion Angle
Periodo de tiempo: 3 months
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It will be evaluated using Kinovea software from recorded gait videos.
Anatomical markers will be positioned on the greater trochanter, lateral femoral condyle, and lateral malleolus.
Knee flexion will be measured during the terminal stance phase.
Changes toward normal knee kinematics will be considered indicative of gait improvement.
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3 months
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Ankle Dorsiflexion Angle
Periodo de tiempo: 3 months
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It will be measured using Kinovea software during gait analysis.
Reflective markers placed on the lower limb and foot will be used to calculate ankle joint kinematics.
Ankle dorsiflexion will be assessed at initial contact.
Increased dorsiflexion toward normal gait values will indicate improved gait performance.
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3 months
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Silla de estudio: Eman Ibrahem El-Hadidy, PhD, Professor, Cairo university
- Director de estudio: Mai Elsayed Abbass, PhD, Ass. Professor, Cairo university
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
20 de junio de 2026
Finalización primaria (Estimado)
20 de septiembre de 2026
Finalización del estudio (Estimado)
30 de septiembre de 2026
Fechas de registro del estudio
Enviado por primera vez
11 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
11 de junio de 2026
Publicado por primera vez (Actual)
16 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
16 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
11 de junio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- P.T.REC/012/006208
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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